The ZIO® SR ECG Monitoring Service is intended to capture, and report symptomatic and/or continuous electrocardiogram (ECG) information for long-term monitoring (up to 14 days). It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, syncope, fatigue, or anxiety. The reported ECG metrics include single-lead analysis on a beat by beat basis, heart rate measurement and rhythm analysis. The report does not contain diagnostic interpretation; the reported analysis is provided for review by the intended user to render a diagnosis based on clinical judgment and experience.

Device Description

The ZIO® SR ECG Monitoring Service consists of three components: (1) ZIO SR Patch Recorder with Bluetooth technology, (2) ZIO SR Wireless Gateway, and (3) ZIO ECG Utilization Service System.

The ZIO® SR Patch is a single-patient-use ECG monitor that provides a continuous, singlechannel recording in addition to symptomatic data transmission for up to 14 days. The ZIO® SR Patch records ECG without patient interaction, with the goal of improving patient compliance via simplicity of operation. Patients have the option of pressing a convenient trigger button which marks the continuous record and initiates a wireless transfer of an ECG strip of 90-second duration. The wireless transfer of data is enabled by the ZIO® SR Gateway, which requires proximity and reception but no patient interaction. The patient is encouraged to fill out a log to document symptomatic events, which will support symptom-rhythm correlation in the ZIO SR Report. Alternatively, the patient can enter symptom logs and view received transmissions via an online patient portal.

At the conclusion of the wear period (up to 14 days), the patient removes the ZIO® SR Patch and returns it by mail to an iRhythm data processing center.

Upon receipt of symptomatic or continuous ECG data at iRhythm's Clinical Center (iCC) the ECG data is downloaded, the data is processed through the algorithm and delivered to the QA Tool module where the results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy. iRhythm employed and trained Patch in-take and CCT personnel follow internal procedures for processing and are of algorithm performance anomalies. Any software anomalies are visible to and manually corrected by iRhythm Technologies CCT's during the QA review and/or Patch Report edits. The CCT generates a final report of the ECG findings contained within the data; thereby enabling the provision of a complete ECG processing and analysis service.

Upon explicit request from a clinician responsible for the patient's healthcare, longer segments of ECG data from the continuous recording on the Patch can also be wirelessly retrieved during the wear period.

Automated ECG analysis performance was quantified for any claimed analysis metrics. The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that certain specific details (like exact performance metrics or sample sizes for specific training sets) are not explicitly stated in this 510(k) Summary document but can be inferred or acknowledged as missing from this specific submission.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Automated ECG Analysis Performance for Analysis Metrics	Satisfy requirements to minimize safety or efficacy concerns.	"The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns." (Specific numerical targets for sensitivity and positive predictivity are not provided in this document.)
All Necessary Performance Testing (covering areas like electrical safety, EMC, biocompatibility)	Met requirements of recognized consensus standards (listed below).	"All necessary performance testing was conducted on the ZIO® SR ECG Monitoring Service to support determination of substantial equivalence to the predicate devices. The results confirm by examination and provision of objective evidence that the design output met the design input requirements in conformance with the following list of recognized consensus standards."

List of Recognized Consensus Standards (which define performance requirements):

ISO 14971:2007/(R)2010 (Medical devices - applications of risk management)
IEC 60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (Medical electrical equipment - general requirements for basic safety and essential performance)
IEC 60601-1-2:2007 (Medical electrical equipment - electromagnetic compatibility)
IEC 60601-1-11 Edition 1.0 2010-04 (Medical electrical equipment - requirements for home healthcare environment)
IEC 60601-2-47:2012 (Medical electrical equipment - requirements for ambulatory electrocardiographic systems)
EC12:2000/(R)2010 (Disposable ECG electrodes)
ISO 10993-1:2009/(R) 2013 (Biological evaluation of medical devices - biocompatibility)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided text. The document refers to "Automated ECG analysis performance was quantified for any claimed analysis metrics" but does not give a specific number of records or patients/recordings used for the test set.
Data Provenance: Not explicitly stated in the provided text. It does not mention the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not explicitly stated for the test set ground truth establishment.
Qualifications of Experts: The document mentions that the results of the algorithm are reviewed and/or adjusted by "iRhythm Certified Cardiographic Technicians (CCT's) for accuracy." While these CCTs perform review and correction of general algorithm output, it's not explicitly stated if they were the ones establishing the gold standard/ground truth for the test set used to validate the algorithm itself, or if a different set of more senior experts (e.g., cardiologists) were involved in creating the ground truth for an independent test set.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated for the test set ground truth establishment. The document describes a post-processing step where "results are reviewed and/or adjusted by iRhythm Certified Cardiographic Technicians (CCT's) for accuracy" in the Clinical Center. This sounds like an internal quality assurance step, but not necessarily the method for establishing a blinded, adjudicated ground truth for a formal validation study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, the provided text does not describe a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance. The described process involves CCTs reviewing and potentially adjusting the algorithm's output, implying a form of human-in-the-loop, but not a formal comparative effectiveness study as typically defined for MRMC.
Effect Size of Improvement: Since no MRMC study is described, no effect size of human reader improvement with AI assistance is provided.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, standalone algorithm performance appears to have been evaluated. The text states: "Automated ECG analysis performance was quantified for any claimed analysis metrics. The resulting statistics demonstrate sensitivity and positive predictivity levels which satisfy requirements and minimize safety or efficacy concerns." This strongly suggests a standalone evaluation of the algorithm's output before any human review or adjustment.

7. The Type of Ground Truth Used

Type of Ground Truth: The document implies an expert consensus or expert review process for establishing ground truth, as it mentions CCTs reviewing and adjusting algorithm output for accuracy. However, it's not explicitly stated whether this was strictly expert consensus from multiple independent reviewers, or a single expert's review, or another form of ground truth like pathology or outcomes data. Given the "CCT's for accuracy" statement, it leans towards expert review.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not explicitly stated in the provided text.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not explicitly stated in the provided text. The document focuses on the operational workflow and validation of the device, not the specifics of the AI model training data or its annotation process.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 19, 2015

iRhythm Technologies, Inc. Rich Laguna Director QA/RA 650 Townsend Street, Ste 380 San Francisco, California 94103

Re: K143513

Trade/Device Name: ZIO® SkyRunner (SR) Electrocardiogram (ECG) Monitoring Service Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH, DOK, DXH Dated: May 15, 2015 Received: May 18, 2015

Dear Rich Laguna:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mitchell Stein

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K143513

Device Name: ZIO® SkyRunner (SR) Electrocardiogram (ECG) Monitoring Service

Indications for Use:

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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SECTION 5 510(k) SUMMARY

This summary of the 510(k) premarket notification for the ZEUS System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

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IRHYTHM TECHNOLOGIES, INC.

K143513

SECTION 5 510(k) SUMMARY

510(k) Notification K

GENERAL INFORMATION

Applicant:

iRhythm Technologies, Inc. 650 Townsend Street, Suite 380 San Francisco, CA 94103 U.S.A Phone: 415-632-5700 Fax: 415-632-5701

Contact Person:

Rich Laguna Director Quality & Regulatory Affairs eMail: rlaguna@irhythmtech.com Phone: 415-632-5749 Fax: 415-632-5701

Date Prepared: December 10, 2014

DEVICE INFORMATION

Classification:

Recorder, Magnetic Tape, Medical, 21 CFR§870.2800 Computer, diagnostic, programmable, 21CFR§870.1425 Transmitters and receivers, electrocardiograph, telephone, 21CFR§870.2920

Product Codes: DSH, DQK, DXH

Trade Name: ZIO®®

Generic/Common Name: Medical magnetic tape recorder

PREDICATE DEVICE(S)

ZEUS (ZIO ECG Utilization Services) System [K142681] ZIO PATCH [K121319] EPI MINI [K121628]

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SECTION 5 510(k) SUMMARY

INDICATIONS FOR USE

PRODUCT DESCRIPTION

The ZIO® SR ECG Monitoring Service consists of three components: (1) ZIO SR Patch Recorder with Bluetooth technology, (2) ZIO SR Wireless Gateway, and (3) ZIO ECG Utilization Service System.

At the conclusion of the wear period (up to 14 days), the patient removes the ZIO® SR Patch and returns it by mail to an iRhythm data processing center.

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SECTION 5 510(k) SUMMARY

SUBSTANTIAL EQUIVALENCE

The indications for use for the ZIO® SR ECG Monitoring Service are substantially equivalent to the indications for use for the predicate devices. The performance testing results demonstrate that any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Therefore, the ZIO® SR ECG Monitoring Service is substantially equivalent to the predicate device.

NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

There are no required FDA performance standards for the ZIO® SR ECG Monitoring Service. All necessary performance testing was conducted on the ZIO® SR ECG Monitoring Service to support determination of substantial equivalence to the predicate devices. The results confirm by examination and provision of objective evidence that the design output met the design input requirements in conformance with the following list of recognized consensus standards:

. ISO 14971:2007/(R)2010 (Corrected 4 October 2007), medical devices - applications of risk management to medical devices
IEC 60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance
IEC 60601-1-2:2007, Medical electrical equipment part 1-2: general requirements for . basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests
IEC 60601-1-11 Edition 1.0 2010-04, medical electrical equipment - part 1-11: general requirements for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
. IEC 60601-2-47:2012, Medical electrical equipment -- part 2-47: particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems. (Cardiovascular)
o EC12:2000/(R)2010, disposable ecg electrodes. (Cardiovascular)
ISO 10993-1:2009/(R) 2013, biological evaluation of medical devices -- part 1: evaluation and testing within a risk management process. (Biocompatibility)

CONCLUSION

The ZIO® SR ECG Monitoring Service is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).